Understanding FDA Compliance Services in the Pharmaceutical Industry

New Delhi, November 18, 2016: The Food and Drug Administration (FDA) is a US federal agency that is responsible for the promotion and protection of public health by making sure that the food products, pharmaceutical and prescription drugs, dietary supplements, veterinary products, radiation-emitting products, medical equipments, cosmetics, vaccines, etc., are effective and completely safe to use/consume. All pharmaceutical companies involved with production, processing or packaging of food or drugs must follow the guidelines, laws and regulations set by FDA. There should be no margin of error when it comes to complying with the FDA regulations.

Importance of FDA Compliance

FDA compliance seems like a lot of work, doesn’t it? There might be times when you would want to skip the process or wonder if it is really that important. Well, no must not skip it and yes, it is really that important. FDA is responsible for a number of things apart from ensuring the safety, security and effectiveness of various food and pharmaceutical products. Some include:

§ Regulating tobacco products to safeguard public health and minimize their use by minors

§ Assisting with speeding up new innovations concerned with safety, affordability and efficacy of medicine, food and healthcare products in addition to promoting awareness of food and medicine use for better health.

§ Tightening the security and improving the supply of food and medical products in the nation to tackle natural and deliberate threats to public health.

It is crucial that you adhere to the FDA regulations as they are developed to ensure that the food and pharma products are always maintained at high quality. By not adhering to FDA compliance, you put the health of your consumers at risk. Additionally, when the required standards are not met, consumers can take legal action and you will be imposed with penalties such as product recalls, fines or even imprisonment. There will be monetary losses and, on top of that, you will be exposed to bad publicity. Your reputation will be at stake and your profits could be affected over a period of time if your consumers deem your products as untrustworthy.

What are FDA Compliance Guidelines?

The FDA compliance policy is a set of validation programs that are designed to provide the FDA personnel a reference model to evaluate the quality of drugs and food products. Basic guidelines are laid down and can be viewed as recommendations. All these programs are not binding upon the FDA or the public, and the personnel is free to use alternative tactics to fulfill the requirements of applicable regulations.

Let us look at some alternative approaches that fulfill the applicable regulations and statutes:

· Reporting FDA Law Violation and Potential Hazards

If there is any instance of violation of FDA regulations, the FDA personnel have to notify their supervisor, who further has a responsibility of taking the right action during the validation program.

· Action Against Products Made from Interstate Shipments

FDA has full jurisdiction over the products that are manufactured from the interstate materials, regardless of whether the finished product is involved with the interstate shipment or not.

· Registration of Food Facilities

All food facilities must receive an official registration from the FDA in order to operate.

· Action against Products or Materials Carrying Disease Hazards

The FDA can take an action against products that are contaminated, contain infections or pose a threat to the public health.

· Movement of Products to and from Foreign Trade Zones

All products that are exported out of Foreign Trade Zone must comply with FDA-enforced laws and regulations as they are considered as a part of the United States under FDA policy.

· Seizure of Prohibited or Illegal Products by the Customs Officials

Prohibited products such as narcotics are banned from entering the United States and the custom officials can seize such products. Other products of foreign origin may also be seized if they are unhygienic, pose a health risk, represent consumer fraud, etc.

· Sampling of Detained Shipments

The importers are allowed to take samples from detained goods which can be sent for analysis or further examination.

Compliance Program Guidance

The compliance program of the FDA consists of instructions for the FDA personnel to determine the pharmaceutical standards while conducting their checks in various facilities. Guidance documents illustrate the Agency’s current thinking on a particular subject. These documents are prepared for the FDA review staff and various drug sponsors in order to provide guidelines for the processing, evaluation and content of applications. Additionally, it also provides guidelines for the design, production, manufacturing and testing of regulated products. The guidance documents also provide consistency in the Agency’s regulation, inspection and enforcement procedures.

The two common guidance documents include Guideline on the Preparation of Investigational New Drug Products (Human and Animal) (PDF – 795KB) and Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (PDF – 98KB). The former lists out practices and procedures for preparing investigational new drug products that comply with certain sections of CGMP regulations for finished pharmaceuticals and the latter provides the Agency’s current thinking on how to evaluate suspicious or out of specification (OOS) test results.

Corporate Comm India(CCI Newswire)